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Soligenix Shares Power Higher Ahead of SGX301 Phase 3 Data Release; Projected $200 Million Revenue Opportunity For CTCL Drug

Newsfile Corp.

Soulstring Media spots a substantial value opportunity in Soligenix, Inc.; Two near-term Phase 3 data releases can seize upon a $400 million drug market opportunity

Miami Beach, Florida--(Newsfile Corp. - January 16, 2020) - Soligenix (NASDAQ: SNGX), a late-stage pharmaceutical company working to improve the current standard of care for numerous rare diseases through the development and commercialization of novel treatments, is nearing the release of topline data after completing final enrollment for SGX301, a pivotal Phase 3 trial targeting the treatment of cutaneous T-cell lymphoma. A successful report may position the company for significant increases to shareholder value before the end of Q1 2020, and ultimately position the company to commercialize its first drug in a market that is estimated at a more than $200 million revenue opportunity.

The Phase 3 (FLASH) clinical trial is focused on the potential benefits of Soligenix's topical drug ointment SGX301, or synthetic hypericin, in the treatment of cutaneous T-cell lymphoma (CTCL). CTCL is a rare type of Non-Hodgkin's Lymphoma that sits high on the list of conditions that has no current or effective drug treatment, pushing Soligenix to fill the demand to serve this unmet medical need. Further, a positive final data set from the SGX301 trial can position the drug to become the front-line standard of care option, replacing the often ineffective cancer treatments that involve the mutation of DNA, most of which are known to cause collateral damage, inclusive of skin damage, and even secondary cancers that must be treated again. Moreover, because there is no current front-line care nor cure for CTCL, doctors have been forced to focus purely on the management of the discomfort caused by the disease's painful skin lesions. SGX301 aims to change the course of treatment protocol.

And, with interim data demonstrating encouraging results, SNGX's SGX301 may be in the unique and sole position to offer a first-in-class method to manage this rare and uncomfortable disease.

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Soligenix Marking Path Toward Catalyst Moment

The coming trial completion and the announcement of SGX301's Phase 3 topline data is an important milestone for Soligenix. And, if final results mimic the interim data, which is powered at 90% statistical significance, the drug would likely be considered a revolutionary breakthrough in the treatment of CTCL, which affects an estimated 20,000 to 30,000 patients in the United States as of 2020.

The differentiation that most separates SGX301 from current, mostly symptom-relieving treatments is its expected effectiveness as well as its route of administration. According to Soligenix CMO Dr. Richard Straube, SGX301 works as a topically applied ointment which reacts to targeted fluorescent lights. These lights release a superoxide which works in a non-mutative method of action to destroy lesion cells while preserving the surrounding healthy cells. Moreover, the fluorescent light source is entirely non-carcinogenic, and this method of treatment, known as photodynamic therapy, is already well known and commonly utilized by dermatologists.

A primary advantage of SGX301 is the relative ease of how the drug is administered. The relatively simple process begins when the patient first applies the proprietary ointment to the CTCL-caused lesions, usually at home and approximately one day before visiting their physician. The 24-hour lapse allows the ointment to be absorbed by the unwanted cancer cells before visiting the physician, who then exposes the lesions to a precisely controlled dose of safe fluorescent light for roughly five to seven minutes. The combined procedure is aiming to confirm the efficacy of the SGX301 dosing during an initial six week observation period to test the effectiveness of the drug and assess the relative benefits compared to the current treatment methods that often involve cell mutation. The design of the trial established three distinct cycles, the first cycle being a double-blind study of approximately 170 patients to evaluate effectiveness in treating three selected lesions observed over six weeks. Soligenix recently announced the final dosing of patients in the study. Thus, the final weeks of observation are already in play.

Cycles two and three are unblinded and are intended to help researchers observe the long term effects and therapeutic value of SGX301 for a period of up to six months, with the first intermediate-stage evaluation done eight weeks after treatment. Secondary endpoints of the trial may help determine whether specific lesion characteristics respond differently to the SGX301 treatment, as well as evaluating the safety of the drug during extended periods of treatment.

It's important to note that the second and third cycles of the trial are intended to better understand the possible effects of extended treatment, and that a real-life application would generally be tailored in length based on patient response and severity of the disease. The investigators participating in this Phase 3 trial have been enthusiastic toward the interim data, noting that a successful trial outcome could position the drug as the front-line option for a disease that has primarily only symptom relief treatment available.

Perhaps the most significant benefit from an investor perspective is that based on a conservative estimate of 20,000 American and European patients having CTCL, an approved SGX301 could translate to an approximately $200 million revenue opportunity and, at the same time, face little to no competition.

As noted, Soligenix management has guided the market to expect the release of topline results during Q1 2020, with additional safety and efficacy data from Cycle Two and Three's extended treatment periods available soon thereafter.

Why Soligenix Now?

Although SGX301 may potentially become the front-line therapy in the treatment of CTCL, Soligenix is advancing several additional portfolio products toward hopeful marketing approval in the relative near-term. Investors appear to be enthusiastic as well, sending shares of Soligenix (NASDAQ: SNGX) considerably higher ahead of the potential value from an approved SGX301. Notably, there are several additional promising and developing opportunities within SNGX's product pipeline. The next catalyst may come from SGX942.

Soligenix's SGX942 program is also generating interest from both physicians and investors based on positive interim data targeting the treatment of oral mucositis, a critical yet unmet medical need that may also represent a more than $200 million market opportunity for Soligenix. The Phase 2 interim data from SGX942 demonstrated promising results during its proof-of-concept trial in 2015-16 when the drug was administered to 111 head and neck cancer patients.

The results showed that the drug provided a 67% reduction in the duration of severe oral mucositis compared to the placebo group and that for the patients at the highest risk for developing oral mucositis, the drug reduced the median duration of severe oral mucositis from 30 days (one month) in the placebo group to just ten days in the treated group. In addition to this 67% reduction in duration, the Phase 2 SGX942 study demonstrated a reduction in the median duration of ulcerative oral mucositis.

Another positive note from SGX942's clinical trials is that the drug has shown itself to be safe, offers minimal side effects, and the known data appears to indicate that those treated with SGX942 during their chemoradiation procedure experienced a higher rate of complete tumor resolution when compared to those in the placebo group.

Consequently, the results contributed to the most critical correlation of benefit that showed a positive trend ("P-value" of <0.1) in overall survival for SGX942 treated patients at one-year follow-up evaluations.

More Clinical Programs Equate To More Potential

In addition to the late-stage Phase 3 drug trials, Soligenix has continued the development and evaluation of its two bio-defense programs, ThermoVax®, and RiVax®, which have been financially supported through non-dilutive government grants and contracts. As with other programs within the company's portfolio, these products have also shown promise in their path to becoming potent treatments for important unmet areas.

The company's flagship bio-defense vaccine program, RiVax® (using ThermoVax®), is a heat-stable vaccine intended to create a strong defense against exposure to the lethal chemical ricin, an extremely hazardous toxin used in chemical warfare.

During a Phase 1a study, Soligenix demonstrated that its vaccine antigen, a mutated version of ricin toxin A chain with no biological activity, is non-toxic and able to induce an immunogenic response. The alum-adjuvanted RiVax® was also shown to be safe and well-tolerated in a Phase 1b study in human volunteers. Notably, the antibodies induced through immunization with RiVax® have demonstrated total protection from a lethal dose of aerosolized ricin in a rhesus macaques vaccine trial conducted in 2015.

Soligenix is expected to seek expedited FDA approval for the vaccine under the "animal rule" that relies on studies successfully conducted in animals, including non-human primates. The vaccine candidate has earned funding through non-dilutive grants awarded from the NIH (over $25 million thus far) and through an up to $24.7 million in contract entered into with the NIH in 2014.

Based on the encouraging data in an important sector, SNGX is also evaluating the opportunity to potentially apply for a priority review voucher (PRV), which can be a valuable asset to the RiVax® program. Notably, these PRV's are transferable, and recent PRV's have traded hands in the biotech and pharma sector at values that exceed $100 million.

Synergistically within the company's portfolio, the therapeutic properties of RiVax® are made available to patients through the use of the company's other developing product, ThermoVax®. ThermoVax® is a proprietary stabilizing technology that enables vaccines comprised of an aluminum salt adjuvant to be kept out of cold storage without the diminishing of the drug's potency. The elimination of the need for cold storage could prove to be an extraordinary achievement, contributing to multi-purpose applications and provide critically needed treatment in the battlefield, during extreme power-outage situations, and large scale triage situations. Also, the stabilizing effect of this technology could open new opportunities for physicians and clinics, inclusive of ease of storage and the ability to more easily create a national and strategic stockpile of essential vaccines.

ThermoVax® has already shown demonstratively positive results with RiVax®, the company's ricin vaccine, with data indicating that the ThermoVax® technology is capable of providing potency protection for the RiVax® vaccine for up to one year at 104° Fahrenheit. Additionally, ThermoVax® demonstrated its ability to protect the potency of vaccine candidates to treat anthrax, HPV, and Ebola for up to twelve weeks at the same high temperatures.

Could 2020 Be The Breakout Year for Soligenix?

As final topline data from the SGX301 nears its release date in the coming weeks, and with data from the SGX942 trial expected by mid-2020, Soligenix could become extremely well-positioned to capitalize on what some analysts consider a more than $400 million combined market opportunity. And, more can come as the bio-defense programs mature through their trials.

And, although the stock tends to trade in correlation with comparative small-cap biotech stocks, Soligenix is starting to break from the trend and move consistently higher despite the slumping broader market conditions for biotech stocks. Since December, the shares in Soligenix are higher by more than 60%.

Moreover, from a cash-on-hand perspective, the company is well-positioned to move trials forward based on its non-dilutive government funding and from its current cash position of approximately $7 million as of its latest filing.

Most important, as long as Soligenix's portfolio continues to show that its treatments provide safe, effective, and long term treatment solutions to those who need it most, the company, and its investors, may benefit from a diverse clinical program that can drive shareholder value higher. Like most biotechs, results will dictate how the market will value Soligenix. But, if the known interim data acts as a clue, topline data may likely impress.

Hence, with at least two potentially catalyst proportioned events expected to be released within the next two to six months, Soligenix may be in the best position in its operating history to increase shareholder value and commercialize products that significantly improve quality of life for patients. And, a win for patients will likely result in a win for investors, as well. As always, do your due diligence, but it may be advantageous to keep Soligenix on your radar and consider catching it while you can.

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